US7244150B1 - Connector and methods of fabrication - Google Patents

Abstract

A connector includes a unitary body defining a hollow center region configured and arranged to receive a proximal contact portion of a lead. The unitary body may define connector pockets and seal features within the hollow center region. The connector pockets can be spaced-apart and may define openings through the unitary body. The seal features may be disposed between the connector pockets.

Description

FIELD OF THE INVENTION

The invention is directed to stimulators and stimulator components and methods of making the devices. The invention is also directed to stimulators and stimulator components with a connector, as well as methods of making the devices.

BACKGROUND OF THE INVENTION

Stimulators have been developed to provide therapy for a variety of disorders, as well as for other treatments. For example, stimulators can be used in neurological therapy by stimulating nerves or muscles, for urinary urge incontinence by stimulating nerve fibers proximal to the pudendal nerves of the pelvic floor, for erectile and other sexual dysfunctions by stimulating the cavernous nerve(s), for reduction of pressure sores or venous stasis, etc.

As one example, spinal cord stimulation is a well accepted clinical method for reducing pain in certain populations of patients. Stimulators have been developed to provide therapy for a variety of treatments. For example, stimulators can be used to stimulate nerves, such as the spinal cord, muscles, or other tissue. A stimulator can include a control module (with a pulse generator), one or more leads, and an array of stimulator electrodes on each lead. The stimulator electrodes are in contact with or near the nerves, muscles, or other tissue to be stimulated. The pulse generator in the control module generates electrical pulses that are delivered by the electrodes to body tissue. As an example, electrical pulses can be provided to the dorsal column fibers within the spinal cord to provide spinal cord stimulation.

BRIEF SUMMARY OF THE INVENTION

In one embodiment, a connector includes a unitary body defining a hollow center region configured and arranged to receive a proximal contact portion of a lead. The unitary body further defines within the hollow center region a plurality of spaced-apart connector pockets. Each connector pocket defines an opening through the unitary body. The unitary body further defines within the hollow center region a plurality of seal features disposed between the connector pockets.

In another embodiment, a stimulation device includes a lead with a proximal contact portion comprising a plurality of contacts, an electronic subassembly, a connector, and a plurality of conductive contacts. The connector receives the proximal contact portion of the lead. The connector includes a unitary body that defines a hollow center region configured and arranged to receive the proximal contact portion of the lead. The unitary body further defines within the hollow center region a plurality of spaced-apart connector pockets. Each connector pocket defines an opening through the connector. The unitary body further defines within the hollow center region a plurality of seal features disposed between the connector pockets. The conductive contacts are disposed in the openings of the connector and are configured and arranged to couple the contacts of the lead to the electronic subassembly.

In another embodiment, a method of making a stimulation device includes forming a connector, disposing a plurality of conductive contacts in the openings through the unitary body, and coupling contacts on a lead to an electronic subassembly through the connector and conductive contacts. The connector includes a unitary body defining a hollow center region configured and arranged to receive a proximal contact portion of a lead. The unitary body further defines within the hollow center region a plurality of spaced-apart connector pockets. Each connector pocket defines an opening through the unitary body. The unitary body further defines within the hollow center region a plurality of seal features disposed between the connector pockets.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following drawings. In the drawings, like reference numerals refer to like parts throughout the various figures unless otherwise specified.

For a better understanding of the present invention, reference will be made to the following Detailed Description, which is to be read in association with the accompanying drawings, wherein:

FIG. 1 is a schematic perspective view of one embodiment of a connector, according to the invention;

FIG. 2 is a schematic cross-sectional view of the unitary body of the connector ofFIG. 1;

FIG. 3 is a schematic cross-sectional view of the unitary body of the connector ofFIG. 1 from a different side;

FIG. 4 is a schematic exterior perspective view of one embodiment of a stimulator system, according to the invention;

FIG. 5 is a schematic overview of components of a system for stimulation, according to the invention;

FIG. 6 is a schematic perspective view of one embodiment of a mold frame, an end pin and a locating feature, according to the invention;

FIG. 7 is a schematic cross-sectional view of one embodiment of a mold insert piece, according to the invention;

FIG. 8 is a schematic cross-sectional view of one embodiment of a mold insert piece, according to the invention;

FIG. 9 is a schematic end cross-sectional view of the mold insert piece ofFIG. 7;

FIG. 10 is a schematic cross-sectional view of one embodiment of mold insert pieces disposed in a mold frame, according to the invention;

FIG. 11 is a schematic cross-sectional view of one embodiment of mold insert pieces disposed in a mold frame, according to the invention; and

FIG. 12 is a schematic cross-sectional view of one embodiment of a unitary body molded around mold insert pieces disposed within a mold frame, according to the invention.

DETAILED DESCRIPTION OF THE INVENTION

The invention is directed to stimulators and stimulator components and methods of making the devices. The invention is also directed to stimulators and stimulator components with a connector, as well as methods of making the devices.

Examples of stimulators are found in U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032; and 6,741,892; and U.S. patent application Ser. No. 11/238,240, all of which are incorporated by reference.

In at least some applications, the electronic subassembly of a stimulator is coupled to the lead, which includes the electrodes of the stimulator. In at least some designs, the lead has several contacts that connect to individual connector contacts via a connector. The connector contacts may be arranged, for example, in a single row, and are generally electrically isolated from each other.

In at least some designs, the spacing and pitch between the individual contacts may vary due to variation in manufacturing processes or components. Such variation can result in misalignment between the contacts of the lead and the individual connector contacts. To address this, in one embodiment, a connector having a unitary body with periodically spaced connector contacts electrically isolates the connections between adjacent pairs of lead contacts and connector contacts. For example, the connector can include spaced-apart connector pockets into which conductive contacts may be inserted.

As one example, a connector includes a unitary body that defines a hollow center region configured and arranged to receive a proximal contact portion of a lead. The unitary body further defines within the hollow center region spaced-apart connector pockets, where each connector pocket defines an opening through the unitary body. Conductive contacts can be disposed in the openings through the unitary body.

FIG. 2 illustrates schematically a cross-sectional view of one embodiment of aunitary body118 of a connector, according to the invention. Theunitary body118 defines ahollow center region124 that is capable of receiving the proximal contact portion of a lead. Suitable materials for theunitary body118 include, for example, silicone and polyurethane. In some instances, theunitary body118 may be formed from more than one material.

Theunitary body118 further defines connector pockets120 within thehollow center region124. Theunitary body118 may include any number of connector pockets120. There may be, for example, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, or more connector pockets120. Preferably, the number of connector pockets120 is equal to the number of contacts on the proximal contact portion of the lead.

In one embodiment illustrated inFIG. 3, the connector pockets120 define anopening134 through theunitary body118. Theopenings134 through theunitary body118 may be located on any side of theunitary body118. Preferably, theopenings134 are all located on the same side of theunitary body118.

The connector pockets120 are spaced-apart. The connector pockets120 may be spaced-apart in any fashion. For example, the connector pockets120 can be regularly (e.g., with a regular period) spaced-apart. In one embodiment, the connector pockets120 are spaced-apart at substantially uniform intervals. Preferably, the connector pockets120 are spaced-apart such that theopenings134 defined by the connector pockets120 can be aligned with the lead contacts of the proximal contact portion of the lead received by theunitary body118.

Theopening134 through theunitary body118 may have any dimensions. Preferably, theopening134 is capable of receiving a conductive contact130 (FIG. 1).Conductive contacts130 may be made of any material that is conductive including, for example, metals, alloys, conductive polymers, conductive carbon, etc. There may be any number of conductive contacts including, for example, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen or moreconductive contacts130. Preferably, the number ofconductive contacts130 is equal to the number of connector pockets120.

Theconductive contacts130 couple the electronic subassembly110 (FIG. 4) to the lead106 (FIG. 4) through the conductors156 (FIG. 1). Optionally, theconductors156 may be insulated by an insulating material except where theconductor156 makes contact with theconductive contacts130,electronic subassembly110, or other components of the electrical circuitry. The insulating material may be any material that is a poor conductor of an electrical signal including, for example, Teflon™, and non-conductive polymers.

In one embodiment, theunitary body118 further defines within the hollow center region124 a stop pocket150 (FIG. 2). Thestop pocket150 is located at the end of theunitary body118 opposite the end from which the lead is inserted.

In one embodiment, theunitary body118 is coupled to aconnector block158 as illustrated, for example, inFIG. 1. Theconnector block158 can be made of any conductive or non-conductive material. Suitable non-conductive materials for theconnector block158 include, for example, non-conductive polymers, polyetheretherketone (PEEK), ceramics, etc. Suitable conductive materials include, but are not limited to, metal, alloys, conductive polymers, conductive carbon, etc.

In one embodiment, theconnector block158 aids positioning and/or securing the proximal contact portion of the lead within thehollow center region124 of theunitary body118. In one embodiment, theconnector block158 has aninsertion opening162 through which the proximal portion of the lead may pass (FIG. 1). Theconnector block158 may also have asecurement opening160 that may be used to secure the proximal contact portion of the lead disposed within thehollow center region124 of the unitary body118 (FIG. 1). Optionally, thesecurement opening160 may be roughly perpendicular to the insertion opening162 (FIG. 1). A pin, screw or other member can be inserted through thesecurement opening160 in theconnector block158 to secure the proximal contact portion of the lead in thehollow center region124 of theunitary body118.

Theconnector block158 may be coupled to any end of theunitary body118. Preferably, theconnector block158 is coupled to the end of theunitary body118 that is opposite the end of theunitary body118 where thestop pocket150 is located.

In one embodiment, theunitary body118 further defines seal features140 (FIG. 2) within thehollow center region124. The seal features140 are located between the connector pockets120. A seal feature(s)140 may also be disposed between aconnector pocket120 and astop pocket150.

Theunitary body118 may include any number of seal features140. There may be, for example, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen or more seal features140. For example, oneseal feature140 is disposed between each pair of adjacent connector pockets120. Aseal feature140 may also be disposed between aconnector pocket120 and aconnector block158. Preferably, the number of seal features140 is one greater than the number ofconductive contacts130.

The seal features140 generally electrically isolate electrical circuitry located in eachconnector pocket120 from the electrical circuitry located in other connector pockets120. For example, the seal features140 may electrically isolate each connection between aconductive contact130 and a lead contact of the lead received by theunitary body118.

FIG. 4 illustrates schematically one embodiment of astimulation system100. The stimulation system includes a control module (e.g., a stimulator or pulse generator)102, anelectrode array104, and at least onelead body106 coupling the control module to the electrode array. Theelectrode array104 and thelead body106 form a lead. Examples of leads include, for example, percutaneous leads and paddle leads. It will be understood that the system for stimulation can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the stimulator references cited herein. The stimulation system or components of the stimulation system, including one or more of thelead body106,electrode array104, and thecontrol module102, may be implanted into the body.

Thecontrol module102 typically includes ahousing114 with anelectronic subassembly110 and, in at least some embodiments, apower source112 disposed within a chamber in the housing. Preferably, the housing is resistant to moisture penetration into the chamber containing the electronic subassembly and power source. In some embodiments, water may diffuse through the housing. Preferably, the diffused water is relatively pure, without substantial ionic content, as deionized water is relatively non-conductive.

Thehousing114 may be made of any biocompatible material including, for example, glass, ceramics, metals, epoxies and polymers (including plastics). In one embodiment, thehousing114 of the control module is formed of a plastic material that resists the transport of moisture into the interior of the housing and is sufficiently sturdy to protect the components on the interior of the housing from damage under expected usage conditions. Preferably, the material of the plastic housing is a hydrophobic polymer material.

Thehousing114 may include additives such as, for example, fillers, plasticizers, antioxidants, colorants, and the like. The thickness of the walls of the housing may also impact the moisture permeability of the housing. A minimum thickness needed to achieve a particular degree of resistance to moisture transport will often depend on the material selected for the housing, as well as any additives.

Optionally, thehousing114 can be covered, in full or in part, with a coating. The coating can be provided to improve or alter one or more properties of thehousing114 including, for example, biocompatibility, hydrophobicity, moisture permeability, leaching of material into or out of the housing, and the like. In one embodiment, a coating can be applied which contains a compound, such as, for example, a drug, prodrug, hormone, or other bioactive molecule, that can be released over time when the stimulator is implanted. (In another embodiment, the housing itself may include such a compound to be released over time after implantation.)

Theconnector144 is disposed in a portion of the housing that is, at least initially, not sealed. This allows the proximal end of thelead106 to be inserted into theunitary body118 of theconnector144. The conductors156 (FIG. 1), or other electrical conduits (not shown) attached to theconductors156, penetrate thehousing114 into the sealed chamber containing theelectronic subassembly110, and are attached to theelectronic subassembly110.

FIG. 5 is a schematic overview of one embodiment of components of a system for stimulation, including an electronic subassembly110 (which may or may not include the power source112), according to the invention. It will be understood that the system for stimulation and theelectronic subassembly110 can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the stimulator references cited herein. Some or all of the components of the system for stimulation can be positioned on one or more circuit boards or similar carriers within a housing of a stimulator, if desired.

Anypower source112 can be used including, for example, a battery such as a primary battery or a rechargeable battery. Examples of other power sources include super capacitors, nuclear or atomic batteries, mechanical resonators, infrared collectors, thermally-powered energy sources, flexural powered energy sources, bioenergy power sources, fuel cells, bioelectric cells, osmotic pressure pumps, and the like including the power sources described in U.S. patent application Publication No. 2004/0059392, incorporated herein by reference.

As another alternative, power can be supplied by an external power source through inductive coupling via theoptional antenna224 or a secondary antenna. The external power source can be in a device that is mounted on the skin of the user or in a unit that is provided near the stimulator user on a permanent or periodic basis.

If thepower source112 is a rechargeable battery, the battery may be recharged using theoptional antenna224, if desired. Power can be provided to the battery for recharging by inductively coupling the battery through the antenna to a recharging unit210 (seeFIG. 5) external to the user. Examples of such arrangements can be found in the stimulator references identified above.

In one embodiment, electrical current is emitted by theelectrodes154 to stimulate motor nerve fibers, muscle fibers, or other body tissues near the stimulator. Theelectronic subassembly110 provides the electronics used to operate the stimulator and generate the electrical pulses at theelectrodes154 to produce stimulation of the body tissues.FIG. 5 illustrates one embodiment of components of the electronic subassembly and associated units.

In the illustrated embodiment, aprocessor204 is generally included in theelectronic subassembly110 to control the timing and electrical characteristics of the stimulator. For example, the processor can, if desired, control one or more of the timing, frequency, strength, duration, and waveform of the pulses. In addition, theprocessor204 can select which electrodes can be used to provide stimulation, if desired. In some embodiments, the processor may select which electrode(s) are cathodes and which electrode(s) are anodes. In some embodiments with electrodes disposed on two or more sides of the housing, the processor may be used to identify which electrodes provide the most useful stimulation of the desired tissue. This process may be performed using an external programming unit, as described below, that is in communication with theprocessor204.

Any processor can be used and can be as simple as an electronic device that produces pulses at a regular interval or the processor can be capable of receiving and interpreting instructions from anexternal programming unit208 that allow modification of pulse characteristics. In the illustrated embodiment, theprocessor204 is coupled to areceiver202 which, in turn, is coupled to theoptional antenna224. This allows the processor to receive instructions from an external source to direct the pulse characteristics and the selection of electrodes, if desired.

In one embodiment, theantenna224 is capable of receiving signals (e.g., RF signals) from anexternal telemetry unit206 which is programmed by aprogramming unit208. Theprogramming unit208 can be external to, or part of, thetelemetry unit206. Thetelemetry unit206 can be a device that is worn on the skin of the user or can be carried by the user and can have a form similar to a pager or cellular phone, if desired. As another alternative, the telemetry unit may not be worn or carried by the user but may only be available at a home station or at a clinician's office. Theprogramming unit208 can be any unit that can provide information to the telemetry unit for transmission to the stimulator. Theprogramming unit208 can be part of thetelemetry unit206 or can provide signals or information to the telemetry unit via a wireless or wired connection. One example of a suitable programming unit is a computer operated by the user or clinician to send signals to the telemetry unit.

The signals sent to theprocessor204 via theantenna224 andreceiver202 can be used to modify or otherwise direct the operation of the stimulator. For example, the signals may be used to modify the pulses of the stimulator such as modifying one or more of pulse duration, pulse frequency, pulse waveform, and pulse strength. The signals may also direct the stimulator to cease operation or to start operation or to start charging the battery. In other embodiments, theelectronic subassembly110 does not include anantenna224 orreceiver202 and theprocessor204 operates as programmed.

Optionally, the stimulator may include a transmitter (not shown) coupled to the processor and antenna for transmitting signals back to thetelemetry unit206 or another unit capable of receiving the signals. For example, the stimulator may transmit signals indicating whether the stimulator is operating properly or not or indicating when the battery needs to be charged. The processor may also be capable of transmitting information about the pulse characteristics so that a user or clinician can determine or verify the characteristics.

Theoptional antenna224 can have any form. In one embodiment, the antenna comprises a coiled wire that is wrapped at least partially around the electronic subassembly within or on the housing.

Any method of manufacture of the components of the system for stimulation can be used. For example, the power source and antenna can be manufactured as described in U.S. patent application Publication No. 2004/0059392. These components can then be placed inside the housing (or, alternatively, the housing can be formed, e.g., molded, around the components).

In one embodiment, a method of making a stimulation device includes forming aconnector144 comprising aunitary body118 and coupling a lead106 to anelectronic subassembly110 through theconnector144. Theunitary body118 of theconnector144 may be formed by any method that results in theunitary body118 defining ahollow center region124 capable of receiving a proximal contact portion of a lead. Theunitary body118 is formed such that theunitary body118 defines connector pockets120 within thehollow center region124. Theunitary body118 may be formed, for example, by molding (including injection molding), casting, etc.

As an example, theunitary body118 can be formed by molding. In one embodiment, anend pin172 is inserted onto one end of amold frame170 as illustrated schematically inFIG. 10. Suitable materials for themold frame170 include, but are not limited to, metal, wood, wax, polymers, and the like. Preferably, themold frame170 is made of a material such that themold frame170 is reusable.

Theinterior surface180 of themold frame170 is generally complementary to the desired external shape of theunitary body118. Preferably, theunitary body118 has a cylindrical exterior shape. Theinterior surface180 of themold frame170 typically defines the dimensions of the exterior of theunitary body118. Preferably, themold frame170 has at least oneopen surface182, which may optionally be sealed with anend pin172. Optionally, the final moldedunitary body118 can be removed from themold frame170 through the at least oneopen surface182 of themold frame170.

Suitable materials for theend pin172 include, but are not limited to, metals, wood, wax, polymers, and the like. Preferably, theend pin172 is made of a material such that theend pin172 is reusable. Theend pin172 may have any shape or dimensions. Preferably, theend pin172 has a shape and dimensions such that theend pin172 may seal anopen surface182 of themold frame170. The end pin may also have a shape of astop pocket150 or aconnector pocket120.

In one embodiment, at least onemold insert piece176 is disposed within the mold frame170 (seeFIGS. 10 and 11). Suitable materials for themold insert piece176 include, but are not limited to, metals, wood, wax, polymers, and the like. Preferably, themold insert piece176 is made of a material such that themold insert piece176 is reusable. In one embodiment, a singlemold insert piece176 is disposed within themold frame170. Optionally, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, or moremold insert pieces176 can be disposed within themold frame170.

In one embodiment, themold insert pieces176 have a shape such that the cumulative shape of all themold insert pieces176 disposed within themold frame170 defines the desired shape of thehollow center region124 of theunitary body118. In one embodiment, themold insert pieces176 have a shape such that, when themold insert pieces176 are located in themold frame170, the exterior surface of the combinedmold insert pieces176 defines the connector pockets120, seal features140, and stoppockets150, if any, of theunitary body118 as illustrated schematically inFIGS. 7 and 8. It will be recognized that, optionally, the end pins172 can also have the shape of astop pocket150 or othermold insert piece176.

In one embodiment, themold insert pieces176 may be located and/or secured into position within themold frame170 by one or more locating features174. The locating features174 may be anything that aids positioning of themold insert pieces176 within themold frame170 or that aids in securing the position of themold insert pieces176 once they are disposed in themold frame170. For example, a cylindrical rod disposed within themold frame170 may act as a locatingfeature174 as illustrated schematically inFIGS. 8,12, and13. Optionally, apositioning aperture178 disposed within amold insert piece176 may act as a locatingfeature174. In one embodiment, apositioning aperture178locating feature174 is illustrated schematically inFIG. 9. Other locating features can include pins in one end of the mold insert piece176 (or end pin172) that correspond with holes in the end of another mold insert piece176 (or end pin172).

In one embodiment, cooperating locating features174 may aid in disposing or securingmold insert pieces176 in themold frame170. For example, a cylindricalrod locating feature174 may act cooperatively with apositioning aperture178locating feature174 disposed within amold insert piece176. In one embodiment, thepositioning aperture178 disposed withinmold insert pieces176 may be used to thread themold insert pieces176 onto the cylindricalrod locating feature174. Pins/holes in the end of the mold insert pieces may also aid in aligning theopening134—creating features.

After disposing the mold insert piece(s)176 in themold frame170, at least oneend pin172 can be used to seal anopen surface182 of themold frame170 as illustrated schematically inFIG. 12.

A material suitable for forming theunitary body118 is then added into themold frame170 containing themold insert pieces176. For example, the material suitable for forming theunitary body118 may be injected into themold frame170. This material may then be allowed to cure, harden, or otherwise solidify. In one embodiment, a polymerizing agent may be added to the material to facilitate curing.

Once theunitary body118 material has cured, hardened, or otherwise solidified, at least one end pin172 (and in some instances, two end pins) is removed. In some instances, theunitary body118 is temporarily deformed (e.g., stretched) to remove one or more of the end pins172. In some embodiments, locatingfeatures174 may also be removed at this time. For example, a cylindricalrod locating feature174 that passes throughpositioning apertures178 of themold insert pieces176 may be removed at this time.

In some embodiments, theunitary body118 is removed from themold frame170. In one embodiment, themold insert pieces176 are then removed from theunitary body118. Themold insert pieces176 may be removed from theunitary body118 in any manner. Optionally, removal of themold insert pieces176 may be aided by altering the properties of the material used to form theunitary body118. For example, theunitary body118 may be formed from polysilicone and the polysiliconeunitary body118 may be swollen by treating the polysilicone with hexane or another material that swells the polysilicone. The swelling of the polysiliconeunitary body118 may facilitate removal of themold insert pieces176 through theopenings134 in theunitary body118. The openings may be temporarily deformed (e.g., stretched) during this process. In such instances, it is preferable that theunitary body118 be made of a suitable material which allows such deformation and then returns to its original shape.

Once themold insert pieces176 are removed, theconductive contacts130 are disposed within the connector pockets120. Theconductive contacts130 may be disposed within the connector pockets120 in any manner. Optionally, disposing theconductive contacts130 in the connector pockets120 may also be aided by altering the properties of the material used to form theunitary body118. For example, theunitary body118 may be formed from polysilicone. The polysiliconeunitary body118 may be swollen by treatment with hexane or another material that swells the polysilicone. Theconductive contacts130 may then be disposed within the connector pockets120 of theunitary body118. As the polysilicone is allowed to dry, the swelling of the polysiliconeunitary body118 decreases, and theconductive contacts130 are disposed within the polysilicone as the polysilicone shrinks around theconductive contacts130. Optionally, adhesive may be used to further attach theconductive contacts130 to theunitary body118.

Conductors156 may then be coupled to theconductive contacts130 by any suitable method including, for example, welding, soldering, and the like. Optionally, theconductors156 may be attached to electrical conduits (not shown) that pass through thehousing114 to the sealed chamber.

In one embodiment, theconnector144 includes aconnector block158 coupled to theunitary body118. Theunitary body118 may be coupled to theconnector block158 by any method that results in theunitary body118 remaining coupled to theconnector block158 under expected usage conditions. For example, theunitary body118 may be coupled to theconnector block158 using an adhesive. Suitable adhesives include, for example, silicones, epoxies, and acrylics. Optionally, theunitary body118 may be coupled to theconnector block158 using a fastening device such as, for example, a screw, pin, etc.

Upon completion, theconnector144 can be permanently or removably disposed in thehousing114 of thecontrol module102. The proximal end of thelead body106 is inserted into theconnector144 prior to or during implantation and optionally secured using theconnector block158. Adhesive or other material may be added to the connector/lead assembly to more securely attach the proximal end of thelead body106 to theconnector144 or seal the interior of theconnector144 from contact with body fluids.

The above specification, examples and data provide a description of the manufacture and use of the composition of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention also resides in the claims hereinafter appended.

Claims (20)

1. A connector comprising:

a unitary body defining a hollow center region configured and arranged to receive a proximal contact portion of a lead, the unitary body further defining within the hollow center region a plurality of spaced-apart connector pockets, wherein each connector pocket defines an opening through the unitary body, and the unitary body further defining within the hollow center region a plurality of seal features disposed between the connector pockets, the connector pockets adapted to receive a plurality of conductive contacts entirely therein except for a part, if any, of the contacts which protrude through the openings.

2. The connector ofclaim 1, wherein the openings through the unitary body are disposed on one side of the unitary body.

3. The connector ofclaim 1, wherein the connector pockets are spaced-apart at substantially uniform intervals.

4. The connector ofclaim 1, wherein the unitary body further defines a stop pocket at an end of the hollow center region.

5. The connector ofclaim 1, further comprising a connector block coupled to the unitary body.

6. The connector ofclaim 1, further comprising the plurality of conductive contacts disposed in the openings through the unitary body.

7. The connector ofclaim 6, further comprising a plurality of conductors coupled to the conductive contacts.

8. The connector ofclaim 1, wherein the unitary body comprises polysilicone.

9. The connector ofclaim 1, wherein at least four conductive contacts are disposed in the openings through the unitary body.

10. A stimulation device comprising:

a lead with a proximal contact portion comprising a plurality of contacts;

an electronic subassembly;

a connector that receives the proximal contact portion of the lead, wherein the connector comprises a unitary body that defines a hollow center region configured and arranged to receive the proximal contact portion of the lead, wherein the unitary body further defines within the hollow center region a plurality of spaced-apart connector pockets, wherein each connector pocket defines an opening through the connector, and the unitary body further defining within the hollow center region a plurality of seal features disposed between the connector pockets and entirely in the connector pockets except for a part, if any, of the contacts which protrude through the openings; and

a plurality of conductive contacts disposed in the openings of the connector and configured and arranged to couple the contacts of the lead to the electronic subassembly.

11. The stimulation device ofclaim 10, wherein the unitary body further defines a stop pocket at an end of the hollow region.

12. The stimulation device ofclaim 10, wherein the connector pockets are spaced-apart at substantially uniform intervals.

13. The stimulation device ofclaim 10, further comprising a connector block coupled to the unitary body.

14. The stimulation device ofclaim 10, further comprising a plurality of conductors that couple the electronic subassembly to the conductive contacts.

15. A method of making a stimulation device that provides electrical pulses to a tissue comprising:

forming a connector comprising a unitary body defining a hollow center region configured and arranged to receive a proximal contact portion of a lead, wherein the unitary body further defines within the hollow center region a plurality of spaced-apart connector pockets, wherein each connector pocket defines an opening through the unitary body, and the unitary body further defining within the hollow center region a plurality of seal features disposed between the connector pockets;

disposing a plurality of conductive contacts in the openings through the unitary body and entirely in the connector pockets except for a part, if any, of the contacts which protrude through the openings; and

coupling contacts on a lead to an electronic subassembly through the connector and conductive contacts.

16. The method ofclaim 15, wherein the connector is formed by molding, and wherein forming a connector comprises:

disposing mold insert pieces in a mold frame;

forming a unitary body around the mold insert pieces; and

removing the mold insert pieces from the unitary body formed around the mold insert pieces.

17. The method ofclaim 16, wherein disposing told insert pieces in a mold frame comprises disposing mold insert pieces in a mold frame using a locating feature.

18. The method ofclaim 15, wherein disposing a plurality of the conductive contacts in the openings through the unitary body comprises swelling the material used to form the unitary body.

19. The method ofclaim 15, further comprising coupling a connector block to the unitary body.

20. The method ofclaim 15, wherein coupling a lead to an electronic subassembly comprises coupling the lead to the electronic subassembly via a plurality of conductors.

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